Oral iron, intravenous iron or discontinuation of therapy for older adults with treatment unresponsive iron deficiency anaemia

Not Applicable

Completed

• Conditions: Iron deficiency anaemia; Haematological Disorders

• Registration Number: ISRCTN98371961
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Study Completion: 2019-12-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Age 65 years or over
2. Haemoglobin of >=85g/L and <=110g/L prior to commencing oral iron
3. Ferritin <100µg/L prior to commencing oral iron
4. Currently taking oral iron at any dose with a minimum of 8 weeks therapy
5. Insufficient response to oral iron therapy (sufficient response defined as improvement in Hb of 20g/L after a minimum of 8 weeks of oral iron therapy)
6. Relevant investigations (including upper and lower GI endoscopies) either already conducted, offered but declined by the patient, or deemed not appropriate by the treating clinician

Exclusion Criteria

1. Active GI cancers
2. Active (unhealed) peptic ulcer disease
3. No ferritin level performed prior to commencing oral iron
3. Bleeding disorders (including being on oral anticoagulants; antiplatelet agents are permitted)
4. Weight loss of >5Kg in the last 3 months (as a possible marker of occult cancer)
5. Estimated GFR of <30ml/min/1.73m2 by CKD-EPI equation
6. Symptomatic chronic heart failure (defined according to the European Society of Cardiology guidelines; note asymptomatic left ventricular systolic dysfunction is not classed as heart failure)
7. Terminal illness (with life expectancy less than 3 months as deemed by the local investigator)
8. Severe cognitive impairment precluding written informed consent
9. Unable to mobilise without human assistance (walking aids are allowed)
10. Previous reaction to intravenous iron
11. Currently participating in, or within 30 days of completion of, another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Co-primary outcomes, measured from recruitment records at the end of recruitment:<br> 1. The rate of randomisation per month across the pilot sites<br> 2. The proportion recruited from each route of recruitment<br>